EasySuite 4K Integrated Operating Room System Model/Catalog Number:… — Class II medical device recall Z-2233-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-07-10, distributed nationwide. A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is
| Recall number | Z-2233-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-04-24 |
| Classified | 2024-06-28 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, HK |
| Quantity | 227 units |
| Reason classes | packaging |
| Serial numbers | BZ-0000004, BZ-0000005, BZ-0000007, BZ-0000008, BZ-0000009, BZ-0000010, BZ-0000015, BZ-0000019, BZ-0000022, BZ-0000030, BZ-0000031, BZ-0000034, BZ-0000035, BZ-0000036, BZ-0000037, BZ-0000038, BZ-0000039, BZ-0000040, BZ-0000042, BZ-0000043, BZ-0000045, BZ-0000046, BZ-0000047, BZ-0000048, BZ-0000049 and 202 more |
Product
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.
Reason for recall
A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2233-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.